Intervention arm – poor responders | Registration period | Intervention phase | Annual follow-up | Disease statusg | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Visit type | Prior to patient entry | Registration | Randomisation (baseline) | Post CRT | MDT | Chemo-therapy for 12 weeks | MDT | surgery | Surgical follow-up | Adjuvant chemotherapy for 12 weeks | 12 | 24 | 36 | 60 |
Timelines |  | ≤4 weeks prior to CRT | During CRT | 4–6 weeks post CRT |  | ≤12 weeks post CRT. Toxicity assessed at end of each cycle |  | 6–12 weeks after pre-op chemo | 6 weeks post surgery | Toxicity assessed at end of each cycle during chemotherapy | Months from end of CRT | |||
Informed consenta | Â | X | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | ||
Check eligibility criteria | Â | X | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | ||
Diagnosis and clinical assessment | Â | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | ||
Randomisation | Â | Â | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | ||
Quality of life | Â | X | Â | Â | Â | Â | Â | Â | X | Â | X | Â | ||
Chemoradiotherapy | Â | Â | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | ||
Blood sampleb | Â | X | Â | X | X | Â | X | Â | X | X | X | Â | ||
Baseline MRI | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | ||
Restaging MRIc | Â | Â | Â | X | X i | Â | Â | Â | Â | Â | Â | Â | ||
Surgery | Â | Â | Â | Â | Â | X | Â | Â | Â | Â | Â | Â | ||
Surgical morbidityf | Â | Â | Â | Â | Â | Â | X | Â | X | Â | Â | Â | ||
Pathologyd | Â | Â | Â | Â | Â | Â | X | Â | Â | Â | Â | Â | ||
Chemotherapyh | Â | Â | Â | Â | X end of each cycle | Â | Â | X end of each cycle | Â | Â | Â | Â | ||
Toxicity assessment | Â | Â | Â | Â | X end of each cycle | Â | Â | X end of each cycle | X | Â | Â | Â | ||
Annual follow-upg | Â | Â | Â | Â | Â | Â | Â | Â | X | X | X | X | ||
Adverse eventse | Â | Â | Â | X | Â | X end of each cycle | Â | Â | X end of each cycle | Â | Â | Â | Â | |
Concurrent medications | Â | X | X | X | Â | X end of each cycle | X | X | X end of each cycle | X | Â | Â | Â |